Senior Director, CMC Lead
1 month ago
Company Overview
Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious disease. The company was founded by Flagship Pioneering on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODETM platform, which allows in-depth characterization of TCR-antigen pairs, and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.
From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire’s team is creating a new pipeline of therapeutic immune medicines enabled from its DECODE discovery platform. Repertoire is currently using its proprietary platform to discover novel epitopes and TCRs from patients with autoimmune diseases such as type 1 diabetes and multiple sclerosis, creating programmable tolerizing mRNA vaccines to restore immune homeostasis in these indications. In oncology, Repertoire’s decoding of tumor-infiltrating lymphocytes and the antigens they target is enabling development of TCR bispecific therapies and mRNA cancer vaccines to treat solid tumors.
Role Overview
We are seeking an experienced CMC leader with experience bringing protein therapeutics from development candidate nomination into clinical development. This senior role, within Protein Engineering and Molecular Sciences, will interface with multiple internal functions and external partners, such as Repertoire preclinical, regulatory, clinical functions and external contract manufacturing. This professional will provide leadership and guidance across the organization in technology transfer and developing and optimizing Repertoire’s manufacturing processes with contract CDMOs.
Key Responsibilities
- Provide CMC expertise and guidance to Development Candidate nomination.
- Identify CDMOs, develop contracts in conjunction with Executive Leadership and Finance.
- Transfer manufacturing processes to CDMOs and manage CDMO activities from candidate nomination through process development, analytical development, and early phase clinical manufacturing to ensure on-time delivery of material for IND enabling and clinical studies.
- Transfer analytical methods to external CROs/CDMOs and provide additional training, troubleshooting, or technical support, as necessary. Manage analytical and stability programs at CROs.
- Establish QA functionality through supervision of an external QA consultant.
- Author and review technical documents and reports for inclusion in CMC sections of regulatory filings.
- Develop goals, operating plans, production milestones, and short and long-term objectives for all production contracts.
- Proactively identify opportunities to accelerate manufacturing to enable clinical start in a compressed timeline.
Qualifications/Experience
- PhD degree in Biochemistry, Biology, Bioengineering, Immunology, or a similar field.
- 12 plus years’ experience in pharma/biotech industry with significant management experience in process development/manufacturing science.
- Experience in research strategy development and operational management of research outcomes through cross-functional and outsourced teams, as well as budget planning and management.
- Protein Biologics Development experience with proteins refolded from E. coli and proteins expressed in CHO cells with oversight of process development for both upstream and downstream.
- Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up .
- Experience developing pre-formulation studies and stability tests of DS and DP for toxicology studies and clinical trials.
- Well-developed understanding of all aspects of drug development with includes direct experience in working with research and clinical organizations.
- Desirable to have experience with bispecific protein products.
- Technical report writing for inclusion in regulatory submissions.
- Strong leadership and people management skills with the ability to work cross-functionally and communicate effectively across functional areas.
- Ability to drive strategic discussions with senior level management and external partners.
- Creates breakthrough approaches within and across functions, if appropriate, to meet stretch goals impacting company direction.
- Domestic and International travel required to support management of CDMOs.
Repertoire is proud to be an Equal Opportunity Employer.
Recruitment & Staffing Agencies: Repertoire Immune Medicines (“Repertoire”) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.
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